Looking Ahead: Pharma Projections for 2016 - & Beyond

Pharma: Your Eyes Wide Open

At least 12 new blockbuster approvals are predicted to successfully pass through the FDA halls in 2016, according to EP 2016 Vantage Preview. These products could each gain over $1 billion in sales in just 4 short years - by 2020, or sooner. And although some blockbusters are losing their patent protection this year, the industry losses may be less than in years past.

However, continued uproar over scrupulous pharma pricing tactics and concern over skyrocketing, unsustainable costs of biologics should give pause to those who are only smelling roses. And the fact that it's a presidential election year only adds fuel to the fire.

The Top 10 Drugs In 2016

Megablockbuster Humira continues to grab headlines. According to EP Vantage 2016, the top 10 drugs by sales are projected to be:

Do you see the pattern? That's right -- biologics. However, several biologics are up for patent loss in the next decade which opens the doors for newly developed and cheaper biosimilars.

Does Humira Have a Biosimilar?

No doubt, many of the 2016 top 10 drugs are very familiar to consumers, who see these direct-to-consumer ads almost nightly during prime time TV. Although AbbVie's Humira continues to hang on to the top spot, the tide has changed for Humira now that the Humira biosimilar Amjevita (adalimumab-atto) from Amgen is FDA-approved.

Of note, Humira makes up a good portion of all profits for AbbVie. In 2015, Humira sales were an astounding $14 billion. However, analysts suggest biosimilar competition for Humira is complicated due to manufacturing, and Amjvita is not interchangeable with Humira without a doctor's OK. Plus, EvaluatePharma predicts Humira to still be the top selling drug domestically and worldwide in 2020. So, even though a biosimilar is approved, it could be some time before patients see a lower adalimumab price tag.

The Top 10 Pharmaceutical Companies

Per the EP Vantage 2016 Preview, the Top 10 pharma companies by expected 2016 sales are:

Pharmaceutical Mergers in 2016: Or Not

Pfizer remains the top pharmaceutical manufacturer in the US, followed by Novartis and Roche. In what was being touted as the largest health care deal in history, Pfizer had previously agreed to buy Allergan for over $150 billion, a deal that was predicted to close by mid-year. The Pfizer-Allergan merger could have resulted in a company worth over $70 billion. However, on April 6th, 2016 it was reported that the deal was off. According to the Wall Street Journal, Pfizer's board nixed the deal that would have relocated Pfizer to Ireland to lower its taxes. U.S. government disapproval of tax "loophole" inversion deals seem to be at play.

The portfolio of the proposed new merger might have included familiar names such as Viagra (sildenafil), Botox (onabotulinumtoxinA), Restasis (cyclosporine), and Linzess (linaclotide).

The Patent Cliff: Hanging on the Edge

Maybe you remember the notorious “patent cliff” era between 2011 and 2015? The patent cliff refers to a period when patents for many of the small molecule blockbuster drugs, such as Nexium (esomeprazole) and Lipitor (atorvastatin), expired. In fact, between 2009 and 2014, over $120 billion in pharmaceutical sales was lost to patent expirations.

This opened the doors for generic companies to make cheaper copies of the brand name drugs, and reap in the profits, too. The first generic company to gain approval can get an exclusive 180 day marketing period, but after that many of these drugs drop drastically in price as competition takes over. But with the recent rise of large molecule biologics, can we really say the patent cliff is over?

Goodbye Blockbusters: Hello Generics?

Besides Humira, there are other big name blockbusters expected to lose patent protection in 2016. In fact, AstraZeneca lost monopoly on its cholesterol drug Crestor (rosuvastatin) in April 2016 as a generic was approved after much litigation. Seroquel XR (quetiapine), a once-daily atypical antipsychotic, gained generic status in 2016; immediate-release quetiapine was already available in the more affordable generic form.

More Generics On Tap

Sildenafil, the generic erectile dysfunction drug for Viagra, was approved in early 2016. Imatinib, generic for (Gleevec), used for leukemia, skin cancers, and other tumors was cleared at the end of 2015. Sun Pharmaceuticals was first to market with the generic Gleevec, previously Novartis' top product, fostering over $4 billion in 2015 earnings.

A few generics that have recently been approved generically in 2016 include Nuvigil (armodafinil) for various sleep disorders and Tamiflu (oseltamivir) for influenza. Oseltamivir should be commercially available before February 2017. Vytorin (ezetimibe/simvastatin), a combo agent to lower cholesterol, is still awaiting a generic OK.

Plus, in the respiratory world there's Teva's ProAir HFA (albuterol) and GSK's Advair Diskus (fluticasone propionate/salmeterol) approaching the end of their patent -- and blockbuster -- lives.

Biosimilars: They Are Finally Here

Europe has been marketing biosimilars for years now, and the US has 4 biosimilar approvals as of September 2016. In fact, according to the RAND Corporation, biosimilars could save the U.S. health system close to $44 billion over the next decade.

Manufacturing a biosimilar is a complicated process. The FDA has wrapped up rules governing biosimilars, and in March 2015 FDA approved the first biosimilar from Sandoz called Zarxio (filgrastim-sndz). Zarxio is an alternative to Amgen's Neupogen; both agents are used to boost white blood cells to help prevent infection after cancer treatments. Plus, in April 2016, the second US biosimilar was approved, Inflectra (infliximab-dyyb) by Celltrion. Inflectra is a tumor necrosis factor (TNF) blocker biosimilar to Janssen’s Remicade. Erelzi (etanercept-szzs) a biosimilar for Enbrel, and Amjevita (adalimumab-atto), a biosimilar to Humira were both approved late summer of 2016.

The Biosimilar Pipeline

What other biologics may be going down the biosimilar path in the near future?

Biologics Neupogen (filgrastim) and Granix (tbo-filgrastim) are both filgrastim products; however, they each went through the full BCPI Act approval process and are not considered “biosimilar”.

Companies such as Amgen, Teva, Hospira and Sandoz are now developing biosimilar products. Amgen alone has at least 5 biosimilars under development according to their investigational pipeline, including rituximab, infliximab, and cetuximab.

Biologics Expiration Dates

Just as with a small molecule drug, the branded biologic patent has to expire first before an approval on a biosimilar can be secured. However, many biologics have a long waiting period before biosimilar competition can affect pricing.

As noted by the Generics and Biosimilars Initiative, upcoming biologic patent expirations include:

Immune Checkpoint Inhibitors: Immune System Boosters

A new class of immunotherapy drug called immune checkpoint inhibitors continues to have breakthrough approvals in 2016. This newer class, which includes Tecentriq (atezolizumab), works by boosting the body’s immune system to attack cancer cells. Roche's Tecentriq is used to treat urothelial cancer, the most common type of bladder cancer. It was approved on May 18, 2016 and is the first programmed death-ligand 1 (PD-L1) inhibitor approved by the FDA.

In studies, 14.8% of patients had at least partial shrinkage of tumors lasting 2.1 to over 13.8 months at the time of analysis. Common side effects with Tecentriq may include fatigue, loss of appetite, and nausea, but more serious side effects can occur with many organ systems. Approved anti-PD-1 immune checkpoint inhibitors include Merck's Keytruda (pembrolizumab) and BMS's Opdivo (nivolumab). Yervoy (ipilimumab) from Bristol Myers Squibb, targets CTLA-4 and is used for metastatic melanoma (advanced skin cancer). In March 2017 Bavencio, a (PD-L1) blocking antibody, received accelerated FDA-approval for the treatment of Merkel cell carcinoma (MCC) and is the first FDA-approved treatment for this indication.

Pharma Changes: Staying Up-To-Date

Change is inevitable in the pharmaceutical world, but hard to keep up with.